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Changes in asthma mortality (5 to 34 age group) in three countries in relation to the introduction of isoprenaline forte in the UK and New Zealand and of fenoterol in New Zealand. (From Blauw 1995. With permission from the Lancet).
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Figure 1

Changes in asthma mortality (5 to 34 age group) in three countries in relation to the introduction of isoprenaline forte in the UK and New Zealand and of fenoterol in New Zealand. (From Blauw 1995. With permission from the Lancet).

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 Inhaled fenoterol market share and annual asthma mortality in New Zealand in persons aged 5 to 34
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Figure 2

 Inhaled fenoterol market share and annual asthma mortality in New Zealand in persons aged 5 to 34

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Study flow diagram.
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Figure 3

Study flow diagram.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 4

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Forest plot of comparison: 1 All‐cause mortality, outcome: 1.1 Overall results.
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Figure 5

Forest plot of comparison: 1 All‐cause mortality, outcome: 1.1 Overall results.

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Forest plot of comparison: 2 Adults and children non‐fatal serious adverse events, outcome: 2.1 Formoterol versus placebo or salbutamol.
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Figure 6

Forest plot of comparison: 2 Adults and children non‐fatal serious adverse events, outcome: 2.1 Formoterol versus placebo or salbutamol.

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Serious adverse events with regular formoterol compared to placebo. In the control group 12 people out of 1000 had serious adverse events over 16 weeks, compared to 19 (95% CI 13 to 27) out of 1000 for the active treatment group.
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Figure 7

Serious adverse events with regular formoterol compared to placebo. In the control group 12 people out of 1000 had serious adverse events over 16 weeks, compared to 19 (95% CI 13 to 27) out of 1000 for the active treatment group.

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Comparison 1 All‐cause mortality, Outcome 1 Overall results.
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Analysis 1.1

Comparison 1 All‐cause mortality, Outcome 1 Overall results.

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Comparison 2 Adults and children non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 2.1

Comparison 2 Adults and children non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 3 Adults and children non‐fatal serious adverse events (without formoterol 24 µg arms), Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 3.1

Comparison 3 Adults and children non‐fatal serious adverse events (without formoterol 24 µg arms), Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 4 Adults with non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 4.1

Comparison 4 Adults with non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 5 Children with non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 5.1

Comparison 5 Children with non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 6 Children with non‐fatal serious adverse events (without formoterol 24 µg arms), Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 6.1

Comparison 6 Children with non‐fatal serious adverse events (without formoterol 24 µg arms), Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 7 Dose comparison: formoterol 24 µg versus 12 µg twice daily, Outcome 1 Serious adverse events.
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Analysis 7.1

Comparison 7 Dose comparison: formoterol 24 µg versus 12 µg twice daily, Outcome 1 Serious adverse events.

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Comparison 8 Adults and children fatal and non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 8.1

Comparison 8 Adults and children fatal and non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 9 Asthma mortality, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 9.1

Comparison 9 Asthma mortality, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 10 Cardiovascular mortality, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 10.1

Comparison 10 Cardiovascular mortality, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 11 Adults and children non‐fatal asthma‐related serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 11.1

Comparison 11 Adults and children non‐fatal asthma‐related serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 12 Adults and children non‐fatal asthma‐related serious adverse events (Novartis data), Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 12.1

Comparison 12 Adults and children non‐fatal asthma‐related serious adverse events (Novartis data), Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 13 Hospitalisations for asthma, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 13.1

Comparison 13 Hospitalisations for asthma, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 14 Adults and children non‐fatal cardiovascular serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 14.1

Comparison 14 Adults and children non‐fatal cardiovascular serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 15 Impact of inhaled corticosteroids on asthma‐related SAEs, Outcome 1 Patients with at least one asthma‐related SAE.
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Analysis 15.1

Comparison 15 Impact of inhaled corticosteroids on asthma‐related SAEs, Outcome 1 Patients with at least one asthma‐related SAE.

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Comparison 16 Adults and children published non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 16.1

Comparison 16 Adults and children published non‐fatal serious adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 17 Adults and children all adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 17.1

Comparison 17 Adults and children all adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 18 Adults and children published adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 18.1

Comparison 18 Adults and children published adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 19 Adults and children all published drug‐related adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 19.1

Comparison 19 Adults and children all published drug‐related adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Comparison 20 Adults and children serious drug‐related adverse events, Outcome 1 Formoterol versus placebo or salbutamol.
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Analysis 20.1

Comparison 20 Adults and children serious drug‐related adverse events, Outcome 1 Formoterol versus placebo or salbutamol.

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Summary of findings for the main comparison. Summary of findings ‐ SAE all ages

Regular formoterol versus placebo or salbutamol for chronic asthma: SAEs in adults and children

Patient or population: patients with chronic asthma

Settings: community

Intervention: regular formoterol versus placebo or salbutamol

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Regular formoterol versus placebo or salbutamol

SAEs ‐ formoterol versus placebo
(follow‐up: mean 16 weeks)

Medium‐risk population

OR 1.57
(1.05 to 2.37)

6646
(19)

⊕⊕⊕⊕
high

10 per 1000

16 per 1000
(10 to 23)

SAEs ‐ formoterol versus salbutamol
(follow‐up: mean 13 weeks)

Medium‐risk population

OR 0.72
(0.37 to 1.43)

2119
(9)

⊕⊕⊕⊝
moderate1

23 per 1000

17 per 1000
(9 to 33)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; OR: Odds ratio; SAE: serious adverse event

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Confidence interval includes the possibility of harm or benefit

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Summary of findings for the main comparison. Summary of findings ‐ SAE all ages
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Summary of findings 2. Summary of findings ‐ mortality (all‐cause)

Regular formoterol versus placebo or salbutamol for chronic asthma

Patient or population: patients with chronic asthma

Settings: community

Intervention: regular formoterol

Comparison: placebo or salbutamol

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo or salbutamol

Regular formoterol

Mortality (all‐cause) ‐ formoterol versus placebo
(follow‐up: mean 16 weeks)

Medium‐risk population

OR 1.52
(0.24 to 9.71)

5463
(14)

⊕⊕⊕⊝
moderate1

0 per 1000

0 per 1000
(0 to 0)

Mortality (all‐cause) ‐ formoterol versus salbutamol
(follow‐up: mean 13 weeks)

Medium‐risk population

OR 0.5
(0.03 to 8.05)

1418
(6)

⊕⊕⊕⊝
moderate1

0 per 1000

0 per 1000
(0 to 0)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Not enough data to assess this outcome

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Summary of findings 2. Summary of findings ‐ mortality (all‐cause)
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Summary of findings 3. Summary of findings ‐ SAE children

Regular formoterol versus placebo or salbutamol for children with chronic asthma: serious adverse events

Patient or population: patients with chronic asthma (children)

Settings: community

Intervention: regular formoterol versus placebo or salbutamol

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Regular formoterol versus placebo or salbutamol

SAEs ‐ formoterol versus placebo
(follow‐up: mean 23 weeks)

Medium‐risk population

OR 2.82
(1.16 to 6.83)

1335
(5)

⊕⊕⊕⊕
high

12 per 1000

33 per 1000
(14 to 77)

SAEs ‐ formoterol versus salbutamol

See comment

See comment

Not estimable

‐

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; OR: Odds ratio; SAE: serious adverse event

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Figuras y tablas -
Summary of findings 3. Summary of findings ‐ SAE children
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Table 1. Study sponsors

Study ID

Sponsor

Bensch 2001

Novartis

Bensch 2002

Novartis

Busse 2004

Novartis

Corren 2007

AstraZeneca

Ekstrom 1998

AstraZeneca

Ekstrom 1998a

AstraZeneca

FitzGerald 1999

Novartis

Hekking 1990

Not reported

Kesten 1991

Novartis

Kozlik‐Feldmann 1996

Not reported

LaForce 2005

Novartis

Levy 2005

Novartis

Molimard 2001

Novartis

Noonan 2006

AstraZeneca

Pleskow 2003

Novartis

SD‐037‐0344

AstraZeneca

Steffensen 1995

Novartis

van der Molen 1997

AstraZeneca

van Schayck 2002

Not reported

Von Berg 2003

AstraZeneca

Wolfe 2006

Novartis

Zimmerman 2004

AstraZeneca
Figuras y tablas -
Table 1. Study sponsors
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Table 2. Proportion of participants using inhaled corticosteroids (ICS)

Study ID

Proportion of participants on ICS

Bensch 2001

51%

Bensch 2002

69%

Busse 2004

64%

Corren 2007

0% (withdrawn)

Ekstrom 1998

86%

Ekstrom 1998a

89%

FitzGerald 1999

100%

Hekking 1990

Not reported

Kesten 1991

62%

Kozlik‐Feldmann 1996

0%

LaForce 2005

67%

Levy 2005

72%

Molimard 2001

100%

Noonan 2006

100%

Pleskow 2003

44%

SD‐037‐0344

100%

Steffensen 1995

87%

van der Molen 1997

100%

van Schayck 2002

95%

Von Berg 2003

82%

Wolfe 2006

62%

Zimmerman 2004

100%
Figuras y tablas -
Table 2. Proportion of participants using inhaled corticosteroids (ICS)
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Table 3. Intrinsic efficacy of beta‐agonists

Drug

Intrinsic efficacy (%)

Isoprenaline, adrenaline

100

Fenoterol

42

Formoterol

20

Salbutamol

4.9

Salmeterol

< 2

Adapted from Hanania 2002. The authors acknowledge that it is difficult to determine the intrinsic efficacy of salmeterol given its high lipophilicity.

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Table 3. Intrinsic efficacy of beta‐agonists
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Comparison 1. All‐cause mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Overall results Show forest plot

14

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

14

5463

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.50 [0.41, 49.49]

1.2 Formoterol versus salbutamol

6

1418

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.47 [0.02, 8.98]
Figuras y tablas -
Comparison 1. All‐cause mortality
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Comparison 2. Adults and children non‐fatal serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

19

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

19

6646

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.57 [1.06, 2.31]

1.2 Formoterol versus salbutamol

9

2119

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.73 [0.37, 1.43]
Figuras y tablas -
Comparison 2. Adults and children non‐fatal serious adverse events
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Comparison 3. Adults and children non‐fatal serious adverse events (without formoterol 24 µg arms)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

18

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

18

5438

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.55 [0.97, 2.48]

1.2 Formoterol versus salbutamol

9

1848

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.41 [0.19, 0.90]
Figuras y tablas -
Comparison 3. Adults and children non‐fatal serious adverse events (without formoterol 24 µg arms)
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Comparison 4. Adults with non‐fatal serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

15

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

15

5311

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.23 [0.76, 1.99]

1.2 Formoterol versus salbutamol

9

2119

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.73 [0.37, 1.43]
Figuras y tablas -
Comparison 4. Adults with non‐fatal serious adverse events
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Comparison 5. Children with non‐fatal serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

5

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

5

1335

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.48 [1.27, 4.83]

1.2 Formoterol versus salbutamol

0

0

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 5. Children with non‐fatal serious adverse events
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Comparison 6. Children with non‐fatal serious adverse events (without formoterol 24 µg arms)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

5

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

5

1164

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.52 [1.15, 5.51]

1.2 Formoterol versus salbutamol

0

0

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 6. Children with non‐fatal serious adverse events (without formoterol 24 µg arms)
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Comparison 7. Dose comparison: formoterol 24 µg versus 12 µg twice daily

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Serious adverse events Show forest plot

5

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Adults (all‐cause)

3

1598

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.35 [0.64, 2.85]

1.2 Children (all‐cause)

1

342

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.20 [0.52, 2.74]

1.3 Asthma SAE

1

3104

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.16 [1.13, 4.11]
Figuras y tablas -
Comparison 7. Dose comparison: formoterol 24 µg versus 12 µg twice daily
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Comparison 8. Adults and children fatal and non‐fatal serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

19

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

19

6646

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.61 [1.09, 2.37]

1.2 Formoterol versus salbutamol

9

2119

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.71 [0.37, 1.38]
Figuras y tablas -
Comparison 8. Adults and children fatal and non‐fatal serious adverse events
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Comparison 9. Asthma mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

12

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

12

4522

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.54 [0.07, 285.25]

1.2 Formoterol versus salbutamol

6

1418

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.49 [0.07, 286.29]
Figuras y tablas -
Comparison 9. Asthma mortality
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Comparison 10. Cardiovascular mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

12

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

12

4522

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.54 [0.07, 285.29]

1.2 Formoterol versus salbutamol

6

1418

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 10. Cardiovascular mortality
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Comparison 11. Adults and children non‐fatal asthma‐related serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

17

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

17

5759

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.99 [1.12, 3.53]

1.2 Formoterol versus salbutamol

9

2119

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.74 [0.29, 1.88]
Figuras y tablas -
Comparison 11. Adults and children non‐fatal asthma‐related serious adverse events
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Comparison 12. Adults and children non‐fatal asthma‐related serious adverse events (Novartis data)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

11

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo (Novartis published data)

10

4138

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.06 [1.57, 5.96]

1.2 Formoterol versus placebo (Novartis integrated database)

1

5631

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.81 [1.54, 5.14]
Figuras y tablas -
Comparison 12. Adults and children non‐fatal asthma‐related serious adverse events (Novartis data)
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Comparison 13. Hospitalisations for asthma

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

7

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

7

3433

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.28 [1.65, 6.52]

1.2 Formoterol versus salbutamol

2

593

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.75 [0.41, 7.49]
Figuras y tablas -
Comparison 13. Hospitalisations for asthma
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Comparison 14. Adults and children non‐fatal cardiovascular serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

8

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

8

3049

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.69 [0.09, 5.21]

1.2 Formoterol versus salbutamol

5

803

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.14 [0.01, 1.33]
Figuras y tablas -
Comparison 14. Adults and children non‐fatal cardiovascular serious adverse events
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Comparison 15. Impact of inhaled corticosteroids on asthma‐related SAEs

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Patients with at least one asthma‐related SAE Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Patients taking inhaled corticosteroids (all doses of formoterol))

1

3807

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.58 [1.21, 5.49]

1.2 Patients not taking inhaled corticosteroids (all doses of formoterol)

1

1824

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.22 [1.17, 8.89]

1.3 Patients taking inhaled corticosteroids (formoterol 12 mcg twice daily)

1

2708

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.76 [1.06, 7.15]

1.4 Patients not taking inhaled corticosteroids (formoterol 12 mcg twice daily)

1

1103

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.71 [0.75, 18.48]
Figuras y tablas -
Comparison 15. Impact of inhaled corticosteroids on asthma‐related SAEs
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Comparison 16. Adults and children published non‐fatal serious adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

7

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

7

1792

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.31 [1.17, 4.53]

1.2 Formoterol versus salbutamol

3

536

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.60 [0.15, 2.44]
Figuras y tablas -
Comparison 16. Adults and children published non‐fatal serious adverse events
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Comparison 17. Adults and children all adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

11

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

11

4884

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.11 [0.98, 1.25]

1.2 Formoterol versus salbutamol

4

1151

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.98 [0.76, 1.26]
Figuras y tablas -
Comparison 17. Adults and children all adverse events
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Comparison 18. Adults and children published adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

8

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

8

3743

Odds Ratio (M‐H, Fixed, 95% CI)

1.09 [0.94, 1.26]

1.2 Formoterol versus salbutamol

4

1151

Odds Ratio (M‐H, Fixed, 95% CI)

0.98 [0.76, 1.26]
Figuras y tablas -
Comparison 18. Adults and children published adverse events
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Comparison 19. Adults and children all published drug‐related adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

4

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

4

2112

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.42 [1.07, 1.88]

1.2 Formoterol versus salbutamol

3

542

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.75 [0.48, 1.18]
Figuras y tablas -
Comparison 19. Adults and children all published drug‐related adverse events
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Comparison 20. Adults and children serious drug‐related adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Formoterol versus placebo or salbutamol Show forest plot

9

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Formoterol versus placebo

9

3618

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.45 [0.18, 11.61]

1.2 Formoterol versus salbutamol

3

746

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.71 [0.04, 12.34]
Figuras y tablas -
Comparison 20. Adults and children serious drug‐related adverse events
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